FDA urged to pull Abbott diet drug from market

Sibutramine, sold under the brand name Meridia, carries heart attack, stroke risks for users with a history of cardiovascular disease.

September 01, 2010|By Shari Roan, Tribune Newspapers

The prescription diet drug sibutramine, sold under the brand name Meridia, should be taken off the market because it raises the risk of heart attacks and strokes in some patients, the editor of the New England Journal of Medicine said Wednesday.

Those risks, published in January on a government clinical-trials Web site and now in full in the journal, outweigh the modest benefits of the medication, said Dr. Gregory Curfman, the journal's executive editor and lead author of an editorial that accompanied the study.

The preliminary results published on the government site showed sibutramine increased the rates of nonfatal heart attacks and strokes in people who had a history of cardiovascular disease and took the medication for an average of 3.4 years. Based on that data, the drug was withdrawn in Europe earlier this year.

The U.S. Food and Drug Administration will hold hearings this month to reconsider the drug's safety. If the medication were to be pulled, that would leave Genentech's Xenical as the only prescription weight-loss medication on the U.S. market other than stimulant medications that are intended only for short-term use.

"Sibutramine doesn't help people," Curfman said. "It doesn't result in very much weight loss, and it doesn't improve their clinical condition. On the other side, it carries these risks."

In exchange for an average weight loss of 8.8 pounds, he said, the patients in the study had a 1 in 70 chance of having a heart attack or stroke.

Sibutramine was approved in 1997, but sales of the drug have been modest. The medication works by altering levels of key chemicals in the brain to decrease appetite. The drug is known to increase blood pressure and heart rate, and it is labeled with a warning that it should not be used in patients with heart disease and should not be taken for more than two years.

After the drug's approval, North Chicago-based manufacturer Abbott Laboratories was asked by European regulators to conduct research on the drug in people with a history of cardiovascular disease, diabetes or both. The randomized study of 9,804 overweight or obese people found that the risk of a stroke, heart attack, cardiac arrest or cardiac death was 16 percent higher among people taking sibutramine compared with those taking a placebo, according to the report published Wednesday.

The findings do not mean the medication is generally unsafe, said the study's lead author, Dr. Philip James, an obesity researcher at the London School of Hygiene and Tropical Medicine. He noted that researchers found no difference in risk among diabetics in the study who took sibutramine compared with diabetics who received the placebo.

"When you give it to people who have not had a heart attack or stroke, we didn't see the effect," James said. "The normal prescription requirements, as long as they are followed by doctors and patients, are fine."

Ninety percent of the patients in the trial would not have been eligible for the drug under the guidelines on the U.S. label, said Scott Davies, a spokesman for Abbott.

"We believe sibutramine has a positive risk-benefit profile when used in the approved patient population," he said.